JPRN-UMIN000022174已完成1 期
Pharmacokinetic study of CNT-01 in healthy adults (Phase I study) - Pharmacokinetic study of CNT-01 in healthy adults (Phase I study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Have a medically significant complication such as digestive, renal, respiratory, endocrine, hematologic, nervous, psychiatric and cardiovascular disorder and inborn errors of metabolism 2) Had an acute disease within 2 weeks before IP administration (e.g., stomachache, nausea, vomiting, anorexia, fever) 3) Took a prescription drug, over the counter drug, nutrient, vitamin or herbal preparation (including Chinese medicine) within 2 weeks before IP administration 4) Have a present condition or known history of drug or food allergy 5) Participated or are currently participating in another clinical study or post-marketing clinical trial within 3 months before IP administration 6)Ingested any medicine, food or beverage (e.g., coffee, tea, chocolate, coke) containing methylxanthine such as caffeine within 48 hours before IP administration 7)Subjects with or suspected of alcohol or drug abuse at screening 8)Ingested any food or beverage containing grapefruit juice, grapefruit, St. Johns wort or Seville orange within 72 hours before IP administration 9) Fall under any of the following -received blood transfusion within 3 months before IP administration -donated whole blood more than or equal to 400 mL within 3 months before IP administration -donated whole blood more than or equal to 200 mL within a month before IP administration -donated blood component within 2 weeks before IP administration 10) Had an infection requiring treatment within a month before IP administration 11) Diagnosed with AIDS or HIV positive 12) Positive for HBs antigen, HCV antibody or syphilis serology test 13) Have eGFR less than 60.0 mL/min/1.73 m2 at screening 14) Women who are or may be pregnant, who are unable to practice contraception properly (e.g., avoiding sexual intercourse, using an intrauterine device) within 12 weeks after IP administration or who are lactating 15) Employed by the CRO related to the study or the medical institution 16) Considered unfit for the study by the investigator
研究者
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